This phase II trial is studying the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells.

Percentage of participants who were alive 30 days after starting induction treatment.

Secondary Outcome Measures:

Event-free Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,

CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3, and 5, and dasatinib PO once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

Drug: daunorubicin hydrochloride

Given IV

Other Names:

Cerubidin

Cerubidine

daunomycin hydrochloride

daunorubicin

RP-13057

Drug: cytarabine

Given IV

Other Names:

ARA-C

arabinofuranosylcytosine

arabinosylcytosine

Cytosar-U

cytosine arabinoside

Drug: dasatinib

Given PO

Other Names:

BMS-354825

Sprycel

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of dasatinib with intensive induction therapy (daunorubicin hydrochloride and cytarabine), consolidation chemotherapy (high-dose cytarabine), and as single agent in maintenance therapy in patients with newly diagnosed core-binding factor acute myeloid leukemia (AML).

CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3, and 5, and dasatinib PO once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: Patients receive dasatinib PO on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 2 months for 2 years, every 3 months for 2 years, and then every year for a up to 10 years.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Newly diagnosed acute myeloid leukemia (AML)

Molecular diagnosis of core-binding factor (CBF) AML by RT-PCR positive for any of the following:

RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) or a variant form

CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22) ort(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of CBFAML based on the WHO classification)

AML with a history of antecedent myelodysplasia (MDS) allowed

Patients who have developed therapy-related myeloid neoplasm (t-MN) after prior radiotherapy or chemotherapy for another cancer or disorder allowed

Must be registered on CALGB-8461 and CALGB-20202 protocols

May also be registered on CALGB-9665

Bilirubin < 2.5 times upper limit of normal

Not pregnant or nursing

Negative pregnancy test

Fertile patients must agree to use two acceptable methods of birth control before, during, and for ≥ 12 weeks after treatment is complete:

No major conduction abnormality (unless a cardiac pacemaker is present)

No patients with congenital QT syndrome or non-congenital QTc prolongation (≥ 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment

No concurrent proton pump inhibitors

No prior chemotherapy for leukemia or myelodysplasia except the following:

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01238211